Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates

Children's Hospitals and Clinics of Minnesota

Status: Terminated

Conditions: Respiratory Distress Syndrome, Newborn; Low Birth Weight Infants; Continuous Positive Airway Pressure

Treatments: Device: RAM Cannula; Device: Binasal Prong CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02168257

47575 (Other Grant/Funding Number)

1303-032

Details and patient eligibility

About

The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.

Enrollment: 8 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low Birth Weight Infant
• Currently on continuous positive aireway pressure of 5-7 cm water pressure
• Receiving continuous positive airway pressure support for > 24 hrs prior to enrollment
• Fraction of inspired oxygen requirement of 23-50%

Exclusion criteria

• Fraction of inspired oxygen > 50%
• Congenital defects of head, pulmonary or cardiovascular systems
• Chromosomal abnormalities/genetic syndromes
• Invasive Surgical Procedure within 24 hrs prior to enrollment
• Enrollment in separate clinical trial that has ongoing data collection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 2 patient groups

RAM Cannula CPAP

Experimental group

Description:

CPAP provided by RAM Cannula

Treatment:

Device: RAM Cannula

Binasal Prong CPAP

Active Comparator group

Description:

CPAP provided by binasal prong

Treatment:

Device: Binasal Prong CPAP